Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide?
Join our growing team and use your exceptional technical and organisational skills to help us deliver on our mission of democratising Data-Driven Medicine.
Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.
Be part of our mission to disrupt the healthcare and democratise the data driven medicine! SOPHiA GENETICS is looking for a Software Validation Engineer to join the Quality Assurance and Regulatory Affairs (QA&RA) team at our headquarters in St-Sulpice, Switzerland.
Reporting to the Knowledge Management Lead, you will be responsible for the maintenance and monitoring of core QARA systems, and for the validation of software company-wide.
You will play a vital role on cross-functional initiatives to validate various in-house and enterprise software such as, but not limited to, our Learning Management System (LMS), Quality Management System (QMS), Digital Asset Management System (DAM), and various software used during product design.
For success in this role you must be comfortable with basic programming, scripting, sys-admin and working on parallel projects with multi-national teams.
You will ensure all software used for QARA functions and company-wide product design and development are kept up to date at all times.
You will ensure compliance of support systems such as MS Active Directory, Atlassian JIRA & Confluence, etc.
You will support internal stakeholders from different departments to ensure that their software meets requirements.
You will write, maintaing and update KM quality documents (SOP’s, forms, Work Instructions).
You will performe routine data backups, inspections and quality tests.
Bachelor’s degree in computer science, data science or related field.
minimum 5 years of experience in IT admin; biotech / medtech industry.
Strong analytical skills, proficiency in one or more programming languages, familiarity with different operating systems, (macOS, Linux, windows).
Strong knowledge and experience with MS Active Directory, ADFS, Atlassian JIRA projects and workflows, Confluence.
Basic knowledge of Software Development Life Cycles;
Programming languages : basic knowledge of Python, Java, Bash.
Good knowledge of NIX systems.
Ability to coordinate projects at multiple levels.
Mandatory C1 english level required (spoken and written)
Requirements elicitation, specification and management
Requirements management tools (e.g. IBM DOORS, Jama Connect, etc.).
Software verification and validation
Proven experience with IQ / OQ / PQ
Specification and execution of verification and validation protocols
Analysis and documentation of test scenarios and test cases
Automation testing platforms (e.g. Bamboo, IBM Rational Test, HP ALM, etc.).
Knowledge of ISO 25065, IEEE Std 830 or other similar standard / guidelines (requirements specification)
Knowledge of IEEE 1012, ISO / IEC 29119 or other related standards (V&V)
Knowledge of GAMP5 or GxP quality guidelines in general
ISO / FDA regulation for software medical devices (e.g. IEC 62034, ISO 14971, FDA 21 CFR 820.30, AAMI TIR45).
FDA 21 CFR 11
Career opportunities in a fast-growing company with worldwide reputation
A flexible and friendly working environment with a collaborative atmosphere
Fantastic office locations in Switzerland.
An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
A fast-growing company with plenty of opportunity for personal growth and development
Start : ASAP
Contract type : full-time